| CTRI Number |
CTRI/2024/06/068306 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Seenthil Chooranam and Yogam for Neerizhivu (Prediabetes) |
|
Scientific Title of Study
|
Evaluation of the therapeutic effectiveness of Siddhar Yogam and Seenthil Chooranam (Internal) in the Management of Neerizhivu (Prediabetes) patients reporting at Ayothidoss Pandithar Hospital of National Institute of Siddha, Chennai - A Comparative,Randomized, Double arm Clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Sumithra |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Tamil Nadu
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9626436232 |
| Fax |
22381314 |
| Email |
rsumithrabsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Tamil Nadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
22381314 |
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Tamil Nadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
22381314 |
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
Tamil Nadu - 600047
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Sumithra |
Ayothidoss Pandithar Hospital |
OPD No-13
Department of Siddhar Yoga Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU |
9626436232
22381314
rsumithrabsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal medicine |
Seenthil Chooranam
Dosage:1.5gm twice a day after food with ghee
Duration:90 days |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Yogam therapy
|
Relaxation techniques
Asthigasanam
Jadaraparivarthini
Bhavanamuthasanam
Vilasanam
Patchimottasanam
Vakrasanam
Makrasanam
Santhiasanam
Nadi suddhi pranayamam
Thiyanam
30-35 minutes,twice a day in an empty stomach
Duration - 90 days
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed Prediabetic subjects with following blood parameters
1) Glucose Tolerance test (140 - 200 mg/dl)
2) HbA1c (5.7 - 6.4 %) |
|
| ExclusionCriteria |
| Details |
1.Other Endocrine abnormalities
2.Any other serious Systemic Diseases
3.Myocardial infarction, vascular surgery and stroke in past year
4.Pregnancy, lactation and planning for pregnant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will be assessed by reduction in the HbA1c after treatment |
Screening-6months
Patient enrollment-6months
Data analysis-1month
Follow up-3months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prediabetes is a serious health condition where blood sugar levels are higher than normal,but not high enough yet to be diagnosed as Type ll Diabetes mellitus .In the Siddha concept,it may be correlated to the Neerizhivu. Prediabetes mainly due to lifestyle modification, unhealthy eating habits,less physical activity, medical health disorder,under any medication .Hence, considerably more patients of Prediabetes (Neerizhivu) have been recorded in the Ayothidoss Pandithar Hospital. The Siddha drug Seendhil Chooranam is said to be cost effective and simple medicine and has Antidiabetic,Immunomodulatory, Hepatoprotective, Analgesic , Anti-inflammatory, Antimicrobial and Anti-histamine activities. Yogasanam plays an important role in the management of blood sugar levels.Yoga can moderate the impact of diabetes is through its effectiveness as a stress -reduction measure.Because high levels of stress hormones like adrenaline and cortisol raise blood sugar levels. So,I hope Seenthil Chooranam and Yogasanam will be effective in the treatment of Neerizhivu (Prediabetes). |